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Yahoo
3 days ago
- Business
- Yahoo
Corcept Presents Results from Phase 2 Study of Dazucorilant in Patients with Amyotrophic Lateral Sclerosis (ALS) at ENCALS 2025 Annual Meeting
DAZALS did not meet its primary endpoint of improved outcome in the ALS Functional Rating Scale-Revised (ALSFRS-R) in patients who received dazucorilant compared to patients who received placebo DAZALS met its secondary endpoint of improved overall survival at week 24 of the study in patients who received 300 mg of dazucorilant compared to patients who received placebo Exploratory analysis at the one-year mark shows continued significant improvement in overall survival between patients who received 300 mg of dazucorilant and those who received placebo only Corcept seeking guidance from United States and European regulators on optimum path forward REDWOOD CITY, Calif., June 05, 2025--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, presented results from its DAZALS study of dazucorilant in patients with ALS at the European Network to Cure ALS (ENCALS) 2025 annual meeting. The presentation can be found here. DAZALS is a randomized, double-blind, placebo-controlled Phase 2 study in which 249 patients with ALS were randomized to receive either 150 mg of dazucorilant, 300 mg of dazucorilant or placebo, daily for 24 weeks. Patients who completed the treatment period were eligible to enroll in a long-term extension study in which all patients received 300 mg of dazucorilant. The primary endpoint in DAZALS was the difference in ALSFRS-R between patients who received dazucorilant and those who received placebo. Overall survival was a secondary endpoint. Although DAZALS did not meet its primary endpoint, patient survival significantly improved. At week 24 of the study, no deaths had occurred in the 83 patients who received 300 mg of dazucorilant, while there were five deaths in the 82-patient placebo group (p-value of 0.02). An exploratory analysis conducted at the one-year mark shows the survival benefit has continued. Patients randomized to 300 mg of dazucorilant lived significantly longer than patients who received placebo and did not switch to 300 mg of dazucorilant in the extension study. The difference between groups was pronounced, with a hazard ratio of 0.16 (p-value: 0.0009). See Figure 1. A similar survival benefit was observed in patients who received 300 mg of dazucorilant for greater than 24 weeks, either in the treatment period or in the extension study, compared to patients who received either placebo or 150 mg of dazucorilant for 24 weeks and did not receive dazucorilant in the extension study (hazard ratio: 0.36; p-value 0.02). See Figure 2. The extension study is ongoing. Dazucorilant has demonstrated an acceptable safety profile, with 92 percent of adverse events being mild to moderate in severity. The frequency of severe and serious adverse events in patients who received dazucorilant was similar to those who received placebo. Mild to moderate, dose-related, transient abdominal pain was the most common adverse effect. "The improvement in overall survival, first noted in the DAZALS study at six months, continues to be seen at one-year. This finding deserves our full attention in service to patients with this tragic disease. Progress in the development of new ALS treatments is of critical importance," said Leonard H. van den Berg, M.D., Ph.D., Professor and Chair in the Department of Neurology, UMC Utrecht Brain Centre, Utrecht, The Netherlands, and Principal Investigator in the DAZALS study. "Medications that can extend life for patients with ALS are urgently needed. We are working with regulatory authorities to determine the optimal path for advancing dazucorilant," said Bill Guyer, PharmD, Corcept's Chief Development Officer. "We would like to thank the patients, their families and care partners, as well as the investigators, doctors and clinic staff involved in this study." About the DAZALS Study DAZALS is a randomized, double-blind, placebo-controlled Phases 2 trial in which 249 patients with ALS were randomized 1:1:1 to receive either 150 mg of dazucorilant, 300 mg of dazucorilant or placebo daily for 24 weeks. Patients who completed the treatment period were eligible to enroll in the long-term extension study in which all patients received 300 mg of dazucorilant. Baseline patient characteristics, including the ENCALS risk score, time from diagnosis, ALSFRS-R total score, and bulbar onset, were consistent across study arms. The DAZALS primary endpoint was the difference in change from baseline during the study's 24-week treatment period in ALSFRS-R score between patients who received dazucorilant and those who received placebo. Key secondary endpoints include overall survival and quality of life. DAZALS was conducted at sites in Europe, the United States and Canada. About Amyotrophic Lateral Sclerosis (ALS) ALS, also known as Lou Gehrig's disease or motor neuron disease, is a fatal degenerative neurologic disorder that affects more than 55,000 people in the United States and Europe. ALS causes muscles to weaken and, as the disease progresses, severely impairs patients' ability to speak, eat, move and breathe. There is increasing evidence that patients with ALS, particularly those with rapid disease progression, exhibit elevated or abnormal cortisol levels. A patient's life expectancy after diagnosis is two to five years. About Dazucorilant Dazucorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but does not bind to the body's other hormone receptors. Corcept is studying it as a potential treatment for ALS and other neurologic disorders. Dazucorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. The U.S. Food and Drug Administration has granted dazucorilant Fast Track Designation and orphan drug status for the treatment of ALS in the United States. About Corcept Therapeutics For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Forward-Looking Statements Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations, which are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those concerning the development of dazucorilant as a treatment for patients with ALS, including the pace, conduct, timing and outcome of DAZALS and its associated long-term extension study, as well as oversight or requirements that may be imposed by the FDA or other regulatory authorities. We disclaim any intention or duty to update forward-looking statements made in this press release. 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Business Wire
12-05-2025
- Health
- Business Wire
MaaT Pharma Announces Promising Final Data Readout for Phase 1b Evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS)
BUSINESS WIRE)--Regulatory News: These encouraging findings from the IASO Phase 1b trial confirm the favorable safety and tolerability profile of MaaT033 in ALS patients. They also highlight the therapeutic potential of microbiome modulation beyond oncology. MaaT Pharma (EURONEXT: MAAT – the 'Company'), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies TM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced additional findings following full data readout for the exploratory single-arm, open-label Phase 1b clinical trial named IASO (NCT05889572) evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS). , the Company announced that the trial had met its primary endpoint assessing the safety and tolerability of MaaT033 with multiple doses, following the independent Data Safety and Monitoring Board (DSMB) conclusion. As a reminder, the exploratory Phase 1b trial enrolled a total of 15 participants across two centers in France Hôpital de la Pitié-Salpêtrière – AP-HP and the University Hospital of Lille. An external Scientific Advisory Committee took place at the end of March 2025 to review the full data. Below are the key takeaways from the Committee's review: MaaT033 demonstrated a favorable safety and tolerability profile, supported by biomarker and microbiome analyses. A rapid and sustained engraftment of bacterial species from MaaT033 was observed, mostly occurring within the first month and maintained during the 1-month follow-up period. A slower rate of disease progression (based on ALSFRS-R slopes) was noted to be interpreted with caution given the short follow up, limited sample size and single-arm Phase 1b design. The ALSFRS-R is a standard functional scale in ALS trials to track the progression of the disease. The slope reflects how many points are 'lost' (=disease progression) per month. In the final data readout for the IASO trial, the following was observed for the ALSFRS-R Total score slope: From first symptoms to baseline, the median slope was –0.7 points/month (range: –1.2 to –0.3) From baseline to Day 84 (D84), the median slope slowed to –0.3 points/month (range: –2.4 to +1.0) No variation at D84 in the levels of neurofilaments, a marker associated with neuronal injury in ALS. In addition, the Scientific Advisory Committee provided insights regarding the best population to target in a Phase 2 trial. 'These encouraging findings from the IASO Phase 1b trial confirm the favorable safety and tolerability profile of MaaT033 in ALS patients. They also highlight the therapeutic potential of microbiome modulation beyond oncology and open new avenues for development in neurodegenerative diseases, as evidence continues to grow around the gut-brain connection," said Gianfranco Pittari, MD, PhD, Chief Medical Officer of MaaT Pharma. The study was conducted in close collaboration with the French patient association Tous en Selles contre la SLA (TECS), highlighting the essential role of patients and their advocates in advancing science, and with the support of experts from the French academic networks FILSLAN and ACT4ALS-MND. 'Recognizing the significant unmet medical need in ALS and with the will to support those affected, we applied our discovery platform to this new disease area, demonstrating its potential beyond our primary focus in oncology with encouraging Phase 1 data. In light of the Company's strict financial discipline, and considering the recent successes achieved in oncology, we are actively seeking partners with a focus on ALS and the financial capacity to support new options to fight this disease," stated Hervé Affagard, CEO and co-founder of MaaT Pharma. –-- About MaaT033 MaaT033, a standardized, donor-derived, high-richness, high-diversity oral Microbiome Ecosystem Therapy TM containing anti-inflammatory Butycore TM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. MaaT033 is developed with the "pooling" technology, which allows pooling donations from multiple donors to create a standardized product with high microbial richness and diversity. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA). About Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease in the US and Charcot's disease in Europe, is a progressive neurodegenerative disorder affecting motor neurons in the brain and spinal cord. This leads to muscle weakness, loss of voluntary movement, and eventually, paralysis and on an average lead to death in 3 to 5 years. ALS could affect up to 60,000 patients in US and EU by 2040 and has currently no curative treatment and few symptomatic treatments. About MaaT Pharma MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021. Forward-looking Statements All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as 'target,' 'believe,' 'expect,' 'aim', 'intend,' 'may,' 'anticipate,' 'estimate,' 'plan,' 'project,' 'will,' 'can have,' 'likely,' 'should,' 'would,' 'could' and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.
Yahoo
05-05-2025
- Health
- Yahoo
AB Science will present new data from masitinib clinical program in ALS in two presentations at the 2025 ENCALS Annual Meeting
PRESS RELEASE AB SCIENCE TO PRESENT NEW DATA FROM MASITINIB CLINICAL PROGRAM IN AMYOTROPHIC LATERAL SCLEROSIS IN TWO PRESENTATIONS AT THE 2025 ENCALS ANNUAL MEETING MASITINIB REDUCES SERUM NEUROFILAMENT LIGHT CHAIN (NFL) LEVELS, SUGGESTING THAT IT HAS DISEASE-MODIFYING POTENTIAL CLINICAL BENEFIT, INCLUDING CAFS AND SURVIVAL, IS GREATEST IN A SUBGROUP OF ALS PATIENTS THAT SERVES AS THE BASIS FOR THE RECENTLY AUTHORIZED PHASE 3 CONFIRMATORY STUDY Paris, May 5, 2025, 6pm CET AB Science SA (Euronext - FR0010557264 - AB) today announced that new analyses from its phase 3 trial in amyotrophic lateral sclerosis (AB10015) and preclinical animal model data have been accepted for presentation at the ENCALS annual meeting (June 3-6, 2025, Turin, Italy). ENCALS is the European network to cure amyotrophic lateral sclerosis (ALS), with abstracts selected by the Scientific Program Committee based on scientific quality. Professor Albert Ludolph, MD, PhD, commented 'These two new abstracts provide valuable data further supporting the potential for masitinib's new phase 3 study to confirm its efficacy based on clinical endpoints and biomarkers such as NfL.' Professor Albert Ludolph, MD, PhD, (Chairman of the Department of Neurology at the University Hospital and Medical Faculty of Ulm), will deliver a poster presentation entitled '. Subgroup analyses were performed within the cohort defined as 'ALS prior to any complete loss of function' (i.e., score ≥1 on each of the ALSFRS-R items), thereby eliminating from baseline any potential confounding zero-item score bias. This is compatible with the mechanism of action of masitinib since masitinib is a disease modifier but is not designed to regenerate motoneurons. Clinical data from the above defined subgroup showed a strong benefit in terms of treatment effect magnitude and consistency across endpoints, in particular on CAFS and a +12-month benefit in survival, thereby supporting the concept that a phase 3 confirmatory study should be performed in ALS patients prior to any complete loss of function. Professor Hayrettin Tumani, MD, PhD, (Head of Laboratory for CSF Diagnostics and Clinical Neurochemistry, Ulm, Germany) will deliver a poster presentation entitled ''. Using a model closely aligned with masitinib's mechanism of action in inflammatory neurodegenerative diseases, masitinib has been shown to reduce serum neurofilament light chain (NfL) levels, thereby decreasing the rate of neuronal damage. Given that chronic neuroinflammation is a hallmark of most neurodegenerative diseases, the observed NfL treatment response suggests that masitinib possess a disease-modifying potential in ALS. About AB ScienceFounded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment. AB Science has developed a proprietary portfolio of molecules and the Company's lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB). Further information is available on AB Science's website: Forward-looking Statements - AB ScienceThis press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance. These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations. For additional information, please contact: AB ScienceFinancial Communication & Media Relations investors@ Attachment ENCALS2025 VENG VFSign in to access your portfolio
Malaysian Reserve
22-04-2025
- Health
- Malaysian Reserve
Cellenkos' Off-the-Shelf Treg Cell Therapy Shows Clinical Safety and Preliminary Efficacy in ALS
Cryopreserved allogeneic Treg infusions associated with slowed disease progression and decreased plasma neurofilament level in ALS HOUSTON, April 22, 2025 /PRNewswire/ — New findings published today in NEJM Evidence reveal promising clinical outcome for Cellenkos Inc.'s cryopreserved, allogeneic, T regulatory (Treg) cells derived from umbilical cord blood, for the treatment of Amyotrophic Lateral Sclerosis (ALS)—a neurodegenerative disease with limited therapeutic options. The study reports that patients receiving multiple intravenous infusions of this 'off-the-shelf' Treg therapy showed a measurable slowdown in disease progression. Prior to therapy, participants' ALS Functional Rating Scale-Revised (ALSFRS-R) scores declined at an average rate of −1.66 points per month. During treatment, that rate slowed significantly to −0.41 points per month, with a modest post-treatment decline of −0.60 points per month—suggesting sustained benefit. Clinical improvements were accompanied by reductions in plasma neurofilament levels, a biomarker correlated with neuronal injury. The Treg therapy was administered in an outpatient setting via peripheral IV, with each patient receiving a standardized fixed dose of 100 million cells. The regimen included weekly infusions for the first month, followed by monthly doses for six months, with optional continued dosing based on physician discretion. The therapy required no lymphodepletion, immunosuppression, interleukin-2, or HLA matching, and patients were discharged the same day. Importantly, no dose-limiting toxicities were reported. Six participants, with a median age of 48.5 years (range: 27–66), and a median baseline ALSFRS-R score of 31.5 (range: 23–43), received a median of 11 infusions (range: 6–22), and all were alive at the time of last follow-up. Among participants with sufficient follow-up data (n=4), the median follow-up duration was 18 months. 'These results are both encouraging and transformative for those battling ALS,' said Dr. Simrit Parmar, Founder of Cellenkos and faculty member at Texas A&M University. 'Unlike conventional cell therapies that require complex, individualized cell harvesting and hospitalization, our Treg therapy is cryopreserved, ready-to-use, and outpatient-based. It eliminates the need for HLA matching and preconditioning. These findings offer a compelling proof of concept and lay the foundation for our next-generation neurotropic Tregs, CK0803.' CK0803 Tregs, now in clinical trials, are modified to overexpress CD11a and CXCR3, improving their ability to migrate to inflamed brain regions, specifically, inflamed microglia — potentially enabling direct targeting of ALS-related pathology. These findings offer renewed hope for patients, families, and researchers working toward more accessible, non-invasive, and effective treatments for ALS. About Amyotrophic Lateral Sclerosis (ALS)ALS is a progressive neurodegenerative disease that affects nerve cells responsible for voluntary muscles. As the disease advances, individuals experience worsening muscle weakness, paralysis, and eventual respiratory failure. Most patients succumb to ALS within three to five years of diagnosis. Currently, there is no cure. About Cellenkos®, Inc. Cellenkos is a clinical-stage biotech company, advancing allogeneic, off-the-shelf, cord blood-derived T regulatory cell therapies for rare inflammatory and autoimmune diseases. Its pipeline includes: CK0801 for Aplastic Anemia CK0802 for Acute Respiratory Distress Syndrome CK0803 for ALS CK0804 for Myelofibrosis Using its proprietary CRANE® platform, Cellenkos tailors tissue directed Treg therapies that require no HLA or ABO matching, can be administered in outpatient settings, and are optimized for rapid, point of care delivery. Contactbd@
USA Today
13-02-2025
- Health
- USA Today
How this Veteran turned grief into purpose
How this Veteran turned grief into purpose Learn how one Veteran with ALS helps others share their stories. After experiencing muscle weakness and twitching in his hand and arm, Michael was diagnosed with amyotrophic lateral sclerosis (ALS) in 2022, almost a year after his symptoms started. At the time, he didn't know much about the condition — whether it could be treated or not, or even that veterans like himself are at an increased risk for developing the disease. ALS is a progressive neurodegenerative disease that currently has no cure. Commonly known as Lou Gehrig's disease, ALS affects nerve cells in the brain and spinal cord, causing weakness and loss of movement. Within three months of his ALS diagnosis, his wife of 33 years passed away unexpectedly. Devastated by the loss, Michael turned his focus to what his children, now in their mid-20s, needed most: the emotional support of their father. Changing priorities 'I knew I needed to be there for them,' Michael said. 'To help them work through this great loss.' It put his desire to learn more about ALS into a new light. 'It became very important to extend my functionality as long as possible so that I can spend more time with my family.' Michael sought out an ALS clinic in his area to explore treatment options that might help him. His neurologist recommended RADICAVA ORS® (edaravone) and explained the benefits and risks of the treatment. In a clinical study, RADICAVA® (edaravone) helped to slow the loss of physical function as measured by the Revised ALS Functional Rating Scale (ALSFRS-R) by 33% compared to a placebo, and RADICAVA ORS® offers the same drug in an oral formulation. The most common side effects of RADICAVA® include bruising (contusion), problems walking (gait disturbance) and headache. Fatigue was also reported in 7.6% of patients taking RADICAVA ORS®. RADICAVA ORS® is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Do not take RADICAVA ORS® if you are allergic to edaravone or any of the ingredients in RADICAVA ORS®. Please see Important Safety Information below and click here for full Prescribing Information and Patient Information. Following his diagnosis, Michael spent the next year visiting as many state parks in North Carolina as he could with his loved ones. His trips reminded him of the 22 years he spent in the Air Force and Air National Guard traveling across the U.S. and around the world. As his symptoms progressed, Michael needed to slow down, but he's never given up. 'You are more adaptable than you think you are, but you do have to reinvent yourself. You're not going to be a physically active person anymore, but there are other things you can do,' he said. A veteran reinvents himself Today, Michael actively advocates for other veterans by spreading awareness of ALS and encourages those who are recently diagnosed to visit a clinic. His work is important because those who have served in the military are twice as likely to develop ALS than those who haven't served. He also remains focused on family, one of his most cherished activities is preparing food with his daughter. 'While I can't physically help her, I can share what I know — how to grill, how to pan-sear meat and some of our favorite family recipes,' he said. They bond over the activity and talk about how to adjust the meal the next time they make it. Learning from each other Recently Michael has discovered that sharing his story and learning about other people's experiences with ALS help him to cope. 'I learned how important it is to stay in the present. Dwelling on what the future may hold can create an unbearable fear.' Through Mitsubishi Tanabe Pharma America's Share Your Story program, people living with ALS and their caregivers can share their own experiences of living with the disease and why treatment with RADICAVA ORS® matters to them. 'Everybody's story might be a little different. You may not relate to someone at all or maybe someone's disease is more progressed than yours — and you may not be ready for that — that's OK, you don't have to read every story, but keep looking, keep reaching out because you'll find somebody that's similar to you and they're adapting in ways that you may not have thought of yet,' he said. Interested in sharing your experience with others? Call a JourneyMateTM Resource Specialist toll-free at 1-855-457-6968 or visit to sign up for the opportunity to share your own story. INDICATION RADICAVA ORS® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS). IMPORTANT SAFETY INFORMATION Do not receive RADICAVA ORS® (edaravone) if you are allergic to edaravone or any of the ingredients in RADICAVA ORS. Before you take RADICAVA ORS, tell your healthcare provider about all of your medical conditions, including if you: have asthma. are allergic to other medicines. are pregnant or plan to become pregnant. It is not known if RADICAVA ORS will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if RADICAVA ORS passes into your breastmilk. You and your healthcare provider should decide if you will receive RADICAVA ORS or breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and overthe-counter medicines, vitamins, and herbal supplements. What are the possible side effects of RADICAVA ORS? RADICAVA ORS may cause serious side effects, including hypersensitivity (allergic) reactions and sulfite allergic reactions. Hypersensitivity reactions have happened in people taking RADICAVA ORS and can happen after your medicine has been taken. RADICAVA ORS contains sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe asthma episodes in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma. Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: hives; swelling of the lips, tongue, or face; fainting; breathing problems; wheezing; trouble swallowing; dizziness; itching; or an asthma attack (in people with asthma). Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects and allergic reactions. The most common side effects of RADICAVA® (edaravone) and RADICAVA ORS include bruising (contusion), problems walking (gait disturbance), and headache. These are not all the possible side effects of RADICAVA and RADICAVA ORS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to or Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058. Please see the full Prescribing Information and Patient Information, also available at Members of the editorial and news staff of USA TODAY Network were not involved in the creation of this content.
